K Number

Device Name

EVA15

Manufacturer

Palliare Ltd.

Date Cleared

2020-10-21

(28 days)

Product Code

HIF FCX

Regulation Number

884.1730

Intended Use

The EVA15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Device Description

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set. There are 3 operating modes: - (a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM) - (b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation). - (c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation). The tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K193520

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "micro-processor-controlled" unit and different operating modes based on flow and pressure, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies rely on the predicate device, further suggesting a lack of novel AI/ML components.

Therapeutic

No
The device description states it is intended for use in "diagnostic and/or therapeutic endoscopic and laparoscopic procedures," but its primary function is to distend a cavity with gas and evacuate smoke, which facilitates the procedure rather than providing direct therapeutic treatment.

Diagnostic

The device is an insufflator designed to distend body cavities and evacuate surgical smoke, facilitating endoscopic and laparoscopic procedures. Its function is to create space for visualization and instrument manipulation, not to diagnose a condition itself. The "diagnostic endoscopic and laparoscopic procedures" mentioned in the intended use refer to the context in which the insufflator is used, not the insufflator's own diagnostic capability.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a "micro-processor-controlled insufflation and smoke evacuation unit" and a "disposable tube set," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the EVA15 Insufflator is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
EVA15 Function: The EVA15 Insufflator is used within the body during endoscopic and laparoscopic procedures. Its function is to distend body cavities with gas and evacuate surgical smoke, facilitating visualization and manipulation during these procedures. It does not analyze any biological specimens.
Intended Use: The intended use clearly states it's for "diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity... and to evacuate surgical smoke." This describes a procedure performed on the patient, not an analysis of a sample from the patient.

Therefore, the EVA15 Insufflator is a medical device used in vivo (within the living body), not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HIF, FCX

Device Description

There are 3 operating modes:

(a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM)
(b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
(c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

The tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdomen, rectum, colon, esophagus, stomach or thoracic cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room or endoscopy suite.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

As the subject device is identical in design to the predicate, performance data from the predicate device were leveraged to support the performance of the subject device.

Key Metrics

Not Found

Predicate Device(s)

K193520

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 21, 2020

Palliare Ltd. % Paul E. Dryden Consultant Palliare Ltd. c/o ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704

Re: K202799

Trade/Device Name: EVA15 Insufflator Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, FCX Dated: September 21, 2020 Received: September 23, 2020

Dear Paul E. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K202799

Device Name EVA15 Insufflator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared:	21-Oct-20
Submitter:	Palliare Ltd.
Galway Business Park, Dangan
Galway H91 P2DK, Ireland
Tel - + 353-91-516362
Official Contact:	John O'Dea, Ph.D., Director
Submission Correspondent:	Paul Dryden
ProMedic, LLC
Proprietary or Trade Name:
Common/Usual Name:	EVA15 Insufflator
CO2 insufflator
Regulation Number:
Regulation Name:
Product Code:
Regulatory Class:	21 CFR 884.1730
Laparoscopic insufflator
HIF, FCX
Class II
Predicate Device:	K193520 - Palliare EVA15

510(k) Summary

The predicate device has not been subject to a design-related recall.

Modification:

The indications for use for the subject device have been modified from that of the predicate to include specific reference to insufflation of the rectum, esophagus, and stomach. There are no proposed design changes in this 510(k). The subject device remains identical in design to the predicate.

Device Description:

There are 3 operating modes:

(a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM)
(b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
(c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

Principle of Operation:

The operating principle employs 2 methods:

(A) A digital insufflation pressure regulation system using compressed CO2 gas to deliver CO2into the patient cavity to be insufflated at the direction and control of the physician and
(B) The use of a venturi method to create a vacuum to evacuate any smoke created during the procedure.

Patient Population:

Patient undergoing laparoscopic or endoscopic procedures in which insufflation may be helpful

Environment of use:

Operating room or endoscopy suite.

Indications for Use:

The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

A comparison of Technological Characteristics of the subject and predicate devices are presented in Table 1 below.

510(k) Summary Table 1 – Comparison – Subject vs. Predicate

	Predicate:	Subject Device:	Comparison
	EVA15 Insufflator - K193520	EVA15 Insufflator
Manufacturer	Palliare	Palliare	Same
Classification	21 C.F.R. § 884.1730
(Laparoscopic Insufflator).
Product Code HIF (Class II)	21 C.F.R. § 884.1730 (Laparoscopic
Insufflator), Product Code HIF,
FCX (Class II)	Similar
Fundamental
scientific
technology	Digital insufflation pressure
regulation system using
compressed CO2 gas. Venturi
smoke evacuation.	Digital insufflation pressure
regulation system using compressed
CO2 gas. Venturi smoke evacuation.	Same
Patient
connection	Standard Trocar luer connection	Standard Trocar luer connection	Same
Indications for
Use	The EVA15 Insufflator is
intended for use in diagnostic
and/or therapeutic endoscopic and
laparoscopic procedures to
distend the abdomen,
colon or thoracic cavity with up
to 15 mmHg pressure, by filling it
with gas and to evacuate surgical
smoke.	The EVA 15 Insufflator is intended
for use in diagnostic and/or
therapeutic endoscopic and
laparoscopic procedures to distend
the abdomen, rectum, colon,
esophagus, stomach or thoracic
cavity with up to 15 mmHg
pressure, by filling it with gas and to
evacuate surgical smoke.	Similar
Gas Delivery
Modes	Fixed Flow
Intermittent Pressure (Standard)
Insufflation
Continuous Pressure Insufflation	Fixed Flow
Intermittent Pressure (Standard)
Insufflation
Continuous Pressure Insufflation	Same
Smoke
Evacuation	Available in all modes. Operates
continuously or may be activated
on/off using foot pedal.	Available in all modes. Operates
continuously or may be activated
on/off using foot pedal.	Same
Flow Range	0-40 SLPM	0-40 SLPM	Same
Pressure Range	7-15 mmHg	7-15 mmHg	Same
Accessories	Tubeset	Tubeset	Same
Dimensions	160x130x330mm	160x130x330mm	Same
Weight	5.5kg	5.5kg	Same
Power Source	100-240V	100-240V	Same
Tubeset
Sterilization	EtO	EtO	Same
User Interface	Membrane Panel	Membrane Panel	Same

K202799

510(k) Summary

Discussion of Differences:

The differences in indications between the subject device and the predicate do not constitute a new intended use.

The subject and predicate device have the same technological characteristics.

Summary of Non-clinical Performance Testing:

As the subject device is identical in design to the predicate, performance data from the predicate device were leveraged to support the performance of the subject device.

Substantial Equivalence Conclusion:

The difference in indications between the subject device and the predicate do not constitute a new intended use. The subject and predicate device have the same technological characteristics. Therefore, the subject device is as safe and effective as the predicate device.